A study issued in March 2015 by the New England Journal of Medicine reveals some disturbing news about clinical drug trials and illegal reporting failures. Only 13% of 13,000 completed clinical trials, which assess the safety and efficiency of drugs, tests, and procedures, were actually submitted to ClinicalTrials.gov (the world’s largest database of past and present clinical trials) within the required one-year window. All of that unpublished data, which should be registered and reported under a 2007 law requiring it, may contain pertinent information about harmful side effects, failed studies for drugs that should have not been released to the market, or information that could lead researchers to question the validity of study findings.
Since the 2007 mandate, however, Journal researchers found that compliance has improved. After 5 years, 41% of industry-funded trials, 28% of academic/non-government-funded trials, and 39% of government-funded trials were reporting results. This movement towards transparency has revamped expectations of the medical research community, notes Deborah Zarin, director of ClinicalTrials.gov. “This is a statement that the expectations have changed: if you’re a researcher or a research sponsor, there’s going to be an expectation that you’re going to make data available at the end of your study,” she commented about the industry change. Sentiments are shared by an Institute of Medicine report, advocating for an “expected norm” in medical research of registered “participant-level” data gathered and shared through open databases.
Though movement towards clinical trial data-sharing has been slow, drug companies, universities, and scientists alike are teaming up in various ways across the U.S. and even in Europe to keep trial sponsors accountable and make this important data available to the public.